University of Michigan-led trial could pave way for FDA approval of simple treatment before that cavities lead to pain, infections, emergency visits, surgery
Study: Efficacy of Silver Diamine Fluoride On Young Children With Severe Early Childhood Caries – A Randomized Clinical Trial (DOI: 10.1001/jamapediatrics.2026.2567)
Every year, untreated tooth decay sends thousands of young U.S. children to emergency departments for dental problems doctors can't treat. Many eventually undergo surgery under general anesthesia, while others endure pain and infection.
A simple, inexpensive liquid called silver diamine fluoride, or SDF, could spare many of those children. Applied to a cavity with a tiny sponge-tipped applicator in about a few second's time per tooth, SDF arrests decay without drilling, shots or sedation.
Dentists have used SDF successfully for decades in many countries, and off label in the United States since 2014, when it was approved as a medical device to treat tooth sensitivity. However, it has lacked the large U.S. population clinical trials for efficacy and safety that are needed for FDA approval as a drug to treat cavities.
Now, a University of Michigan-led clinical trial has produced that evidence.
Published in JAMA Pediatrics, the Phase III trial enrolled 830 children under age 6 who were recruited through dental offices, pediatric medical practices, Head Start and Early Head Start programs in Michigan, New York and Iowa.
Researchers found that 38% SDF arrested tooth decay in more than half of children's affected baby teeth when treated at 6-month intervals. Unlike conventional treatment, which removes part of the tooth before placing a filling, SDF is simply painted onto the cavity.
"This is a very effective and safe treatment-even in children as young as 1," said Margherita Fontana, professor of dentistry at the University of Michigan School of Dentistry and the study's lead investigator.
Tooth decay is the most common chronic disease of childhood, affecting more than 40% of U.S. children. Left untreated, cavities can cause severe pain, infection, difficulty eating and sleeping, missed school and repeated medical visits.
SDF may be especially valuable for very young children, older adults, people with developmental or physical disabilities, patients with severe dental anxiety, and others who cannot easily tolerate or access conventional dental treatment, Fontana said.
Its primary drawback is cosmetic, she said. The silver permanently darkens the decayed portion of the tooth.
"If we want more children and families to benefit from this treatment, we need rigorous evidence showing both that it works and that it's safe. From a public health perspective, if we want broader implementation across the United States, including in medical settings, we need carefully collected data in U.S. populations, and we now have that," Fontana said.
The study began in 2018 and progressed even with the challenges of the COVID-19 pandemic.
"In medicine, clinicians want high-quality evidence before changing practice," Fontana said. "It is important to have data they can refer to because young children often see pediatricians years before they ever visit a dentist, broader acceptance could allow many more cavities to be treated while a referral to a dental home is successful, and before they become painful, infected or require surgery."
Fontana and co-researchers from New York University, the University of Iowa and Indiana University, together with the NIH's National Institute of Dental and Craniofacial Research, which provided over $12 million in funding, completed a study that provides clinical trial data needed by the manufacturer to submit a dental caries drug application to the FDA. The product used in this trial, Advantage Arrest 38% SDF, was provided by Elevate Oral Care.
Amr Moursi, professor of pediatric dentistry at New York University College of Dentistry, said the study provides important data for broadening use of SDF.
"Our results support FDA approval of SDF for managing arrest of tooth decay in young children. Removing SDF from off-label status would be an important innovation which could lead to increased utilization by providers, enhanced payments by insurers and more consistent product quality," said Moursi, a co-principal investigator on the study.
For some children, reapplying SDF every few months may be all that's needed until the baby tooth naturally falls out. For adults, it may serve as a long-term treatment or as a bridge until restorative procedure is affordable or practical.
"For almost anyone, this can arrest the decay and stop the infection and the pain it causes," Fontana said. "This could benefit many people."
